Evidence map›Paper›PMID 36433806›Full record

ArticleJournal of diabetes science and technology2024

User Performance Evaluation and System Accuracy Assessment of Four Blood Glucose Monitoring Systems With Color Coding of Measurement Results.

Stefan Pleus, Annette Baumstark, Sebastian Schauer, Julia Kölle, Nina Jendrike, Jochen Mende, Cornelia Haug, Guido Freckmann

Registry-linked trialAbstract read
In one paragraph

Article in Journal of diabetes science and technology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06509282 (Efficacy of a Personalized Concurrent Exercise Prescription Guide for Controlling Cardiovascular Risk and Enhancing Physical Fitness in Adults From a Cardiovascular Health Program), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06509282 nacompletednot on this map

Efficacy of a Personalized Concurrent Exercise Prescription Guide for Controlling Cardiovascular Risk and Enhancing Physical Fitness in Adults From a Cardiovascular Health Program: A Pilot Randomized Controlled Clinical Trial.

TypeinterventionalSponsorUniversidad San SebastiánRan2023 to 2024Enrolled39ConditionsCardiovascular Syndrome, MetabolicArmsConcurrent training
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Stefan PleusInstitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0003-4629-7754
Annette BaumstarkInstitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0002-3439-7400
Sebastian SchauerInstitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0002-9873-0989
Julia KölleInstitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
Nina JendrikeInstitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
Jochen MendeInstitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0001-8667-760X
Cornelia HaugInstitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
Guido FreckmannInstitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0002-0406-9529

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBlood glucose monitoring systems (BGMSs) are a cornerstone in diabetes management. They have to provide sufficiently accurate results in the hands of lay users, particularly in insulin-treated patients. The aim of this study was user performance evaluation and system accuracy assessment of four BGMSs with color coding of results.

methodsStudy procedures were based on ISO 15197:2013. User performance evaluation included data from 100 participants, each of whom used every system with one reagent lot. Study personnel observed user techniques. For the system accuracy assessment, 100 capillary samples were obtained for measurement in duplicate with each of three reagent system lots per system, resulting in 600 results per system.

resultsAll assessed BGMSs exhibited a sufficient level of accuracy, with small differences between them. In the user performance evaluation, study personnel observed the smallest total number of user errors with Contour Next (Ascensia), followed by Accu-Chek Instant (Roche), Medisafe Fit Smile (Terumo), and OneTouch Ultra Plus Reflect (LifeScan). Approximately 90% of participants stated that a consistent color scheme, eg, for low blood glucose (BG) values, should be used across all BGMSs. There was no clear preference among the four tested BGMSs regarding the specific way of displaying color coding.

conclusionsThe four BGMSs assessed in this study showed only small differences in an overall sufficient level of accuracy. User handling errors, as observed by study personnel, differed between the systems.

Indexed as

Blood GlucoseBlood Glucose Self-MonitoringAdultColorDiabetes MellitusFemaleHumansMaleMiddle AgedReproducibility of ResultsYoung AdultBlood GlucosebiasISO 15197linear regressionself-monitoring of blood glucosesystem accuracyuser performance

Identifiers

PMID36433806
PMCPMC11089863

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.